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The Pharmacy Assurance process coordinates a single technical pharmacy review for eligible studies, which can be used by all participating NHS (or HSC in Northern Ireland) study sites across the UK. This saves sites from conducting their own, separate technical pharmacy reviews.

The Pharmacy Assurance process was developed in conjunction with the Experimental Cancer Medicines Centre and the Four Nations Pharmacy Assurance Working Party, a UK-wide group of pharmacy experts who continue to provide us with expert input.

The completed review provides assurance to study sites that they have all of the information available to assess local capacity and capability and to ensure that the study is deliverable.

This reduces duplication in the pharmacy review of new studies, aiming to help shorten study set-up times. 

The process is open in England, Scotland and Wales, with the process opening in Northern Ireland once a phased roll-out is complete in England and Wales.

Pharmacy Assurance will be a component of HRA and HCRW Approval once a phased implementation is completed. Until then, Pharmacy Assurance will remain an optional separate process. 

Can I submit for Pharmacy Assurance?

Pharmacy Assurance is currently going through a phased roll-out in England and Wales. 

Detailed submission guidance is available on the IRAS website, but our Applying for Pharmacy Assurance page provides an overview for those going through the process.

What are the benefits of this process?

Pharmacy Assurance has been designed to: 

  • give greater clarity to sponsors and study teams at the outset about the information requirements for sites to review and set up studies
  • release staff time currently spent on completing parallel reviews and raising similar queries at multiple sites
  • give reviewers the authority to provide useful feedback and, if necessary, to challenge the study team at an early point of the site set-up process
  • standardise the technical review process for pharmacy studies
  • reduce the number of queries which sponsors receive from pharmacy departments, enabling them to concentrate on resolving local issues

By achieving the above, we aim to streamline the local pharmacy capacity and capability assessments. 

Still got questions?

Visit our FAQs page.

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